Abstract

In recent times, the overall interest over Supercritical Fluid Chromatography (SFC) is truly growing within various domains but especially for pharmaceutical analysis. However, in the best of our knowledge modern SFC is not yet applied for drug quality control in the daily routine framework. Among the numerous reported SFC methods, none of them could be found to fully satisfy to all steps of the analytical method lifecycle. Thereby, the present contribution aims to provide an overview of the current and past achievements related to SFC techniques, with a targeted attention to this lifecycle and its successive steps. The included discussions were therefore structured accordingly and emphasizing the analytical method lifecycle in accord with the International Conference on Harmonisation (ICH). Recent and important scientific outputs in the field of analytical SFC, as well as instrumental evolution, qualification strategies, method development methodologies and discussions on the topic of method validation are reviewed.

Highlights

  • The use of supercritical fluid as mobile phase was firstly suggested by Lovelock in 1958 to extend applications of gas chromatography to solid or/and ionic compounds [1]

  • In 1962, while working on the separation of porphyrins, Klesper, Corwin and Turner made the first demonstration of Dense Gas Chromatography which is nowadays known as Supercritical Fluid Chromatography (SFC) [2] [3]

  • This review focuses on the analytical method lifecycle with an attention to pharmaceutical achiral applications

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Summary

Introduction

The use of supercritical fluid as mobile phase was firstly suggested by Lovelock in 1958 to extend applications of gas chromatography to solid or/and ionic compounds [1]. These modern instruments allow benefiting from the valuable advantages of the SFC: 1) orthogonal selectivity with liquid chromatography, 2) high chromatographic efficiency, 3) high throughput, 4) compatibility with a large range of detectors, 5) short equilibration time, 6) low cost of analysis per sample, 7) low solvent consumption and, 8) low waste generation [9] This technique is recognized and well placed as an alternative to LC [6] [10]-[14] with a particular advantage to be a useful tool in the framework of green analytical chemistry [4]. The discussions will rely on the method lifecycle steps as shown in the Figure 1, mainly through the ones leading to potential routine use of SFC methods it is still not described

Prior Knowledge in SFC
Particular Literature Overview
Scientific and Regulatory Context
The Current Case of SFC
Flow Rate Measurement in SFC
Quality by Testing and Quality by Design
QbT Methodology and SFC
QbD Methodology and SFC
Method Development and SFC
Method Validation in the Field of SFC
Validated SFC Methods
Application of the Total Error Approach to SFC Methods
Findings
Outcomes and Perspectives
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